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Bioethics and Medical Experts Join Chorus of Criticism of Inadequate Consent Procedures in NIH Baby Study

June 27, 2013

Forty-five experts have declared that a federally funded trial involving premature infants used “seriously deficient” consent forms that violated requirements for clinical trials.

In a letter published Wednesday in The New England Journal of Medicine (NEJM), available at http://www.nejm.org/doi/full/10.1056/NEJMc1308015, the 45 doctors, bioethicists and scholars criticized the consent forms used in the SUPPORT trial, which took place in approximately two dozen prominent research facilities throughout the country from 2005-2009. In the trial, 1,316 premature infants were exposed to an increased risk of blindness and death. One primary purpose of the research, funded by the National Institutes of Health (NIH), was to determine whether extremely premature infants were more likely to die if treated with high or low amounts of oxygen.

The Office for Human Research Protections also has found the consent forms to be inadequate.

The experts noted that the risks to the babies in the study were not the same as the risks they would have encountered had they received the usual routine care outside the study. The risk of a baby dying was indeed foreseeable, which the consent form didn’t mention, they noted. The law requires consent forms to include, among other things, a description of any reasonably foreseeable risks.

Since Public Citizen publicized the trial in April (http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3859) and called for similar trials to be halted, a controversy has raged in the scientific community over what kind of consent is needed in clinical trials. The debate goes to the heart of how research is conducted in the United States and could have far-reaching implications if changes are made to the standards by which trials are run.

“None [of the forms] specifically mentioned death as a possible risk of the oxygen interventions in the study,” the experts wrote in the NEJM letter. “The oxygen interventions in the study differed from usual clinical care, and that information should have been included in the consent forms.”

In addition, Public Citizen has subsequently learned that problems with the study extend beyond the consent forms; the oxygen monitors were deliberately miscalibrated so that the doctors treating the infants didn’t know how much oxygen they were receiving. This miscalibration, done for the purpose of the oxygen experiment, could have adversely affected numerous critically important clinical decisions regarding the care of these babies beyond those related to oxygen treatment. However, parents of study babies weren’t informed about these risks either.

For more information about the trial, please visit http://www.citizen.org/hrg2111.

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